Amm Cal, Bil Cal, CO2 Cal, Hdl Cal, Iron/Mg Cal, Ldl Cal, Mc Cal, Upro Cal, and Ise Calibrator Levels 1 and 2

510(k) K981706

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK981706	Date9 Jul 1998Cleared	StatusActive

3 recalls · FDA

- Terminated Z-0950-2009 FDA Unclassified (pre-2012) initiated 24 Apr 2008
An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the incorrect Magnesium CAL 2 value causes quality control and patient magnesium results to be reduced by as much as 17.24% above 0.8mEq/L (1.0 mg/dL or 0.4 mmol/L).
- Terminated Z-0288-2008 FDA Unclassified (pre-2012) initiated 10 Aug 2007
Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.
- Terminated Z-0516-06 FDA Unclassified (pre-2012) initiated 23 Dec 2005
The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. The expiration date for Lot number 26674M100 will be revised from 2006-07-31 to 2006-01-31.

1 jurisdiction

United States — FDA 510(k) Active

510(k)